Lorazepam

ANDA 71118, held by Watson Labs. Lorazepam.

As of Nov 13, 2026, ANDA 71118 (Lorazepam), held by Watson Labs, was first approved by FDA on Jul 24, 1986, with 7 approved supplements and 0 published complete response letters.

First approved: Jul 24, 1986
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Jul 24, 1986	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Lorazepam1MG · tablet;oral	Lorazepam	Discontinued

All 8 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Sep 3, 1993	Supplement 8Labeling	Approved	None posted
Aug 7, 1991	Supplement 6Manufacturing	Approved	None posted
Jan 28, 1991	Supplement 7Manufacturing	Approved	None posted
Jun 29, 1990	Supplement 5Manufacturing	Approved	None posted
Sep 7, 1988	Supplement 3Manufacturing	Approved	None posted
Sep 7, 1988	Supplement 2Manufacturing	Approved	None posted
Jul 8, 1988	Supplement 4Labeling	Approved	None posted
Jul 24, 1986	Original application	Approved	None posted

Identifiers

Application: ANDA 71118
Drugs@FDA: Overview at FDA
Company: Watson Laboratories

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters